FDA approves Artus CMV QS-RGQ MDx test for cytomegalovirus diagnostics- Qiagen

Qiagen has received premarket approval from the U.S. Food and Drug Administration (FDA) for its automated Artus CMV QS-RGQ MDx kit for use on Qiagen�s QIAsymphony platform, providing fast, reproducible test results for use as an aid in the management of solid organ transplant patients who are undergoing anti-cytomegalovirus (CMV) therapy.

Comment: Patients who have undergone organ transplantation have an elevated risk of infection from cytomegalovirus, which is a common virus that infects people of all ages. Over half of all adults by age 40 have been infected with CMV, according to the U.S. Centers for Disease Control. Once CMV is in a person�s body, it stays there for life in latent form and can reactivate. Among organ transplant patients, an estimated 40-70% of post-transplant mortality is linked to higher susceptibility to opportunistic infections such as CMV.